drugset / Trial / NCT03479502

Intra-articular Doxycycline: A Novel Treatment of Adhesive Capsulitis

NCT03479502

RandomizedParallel-groupTriple-blindTreatment

Summary

We will recruit a total of 40 patients from the Vanderbilt Sports Medicine Clinics who have been diagnosed with adhesive capsulitis and have not undergone any previous treatment. The 40 patients will be randomized, with 20 in the control group of 3 intra-articular injections of 40mg Methylprednisolone spaced every two weeks, and 20 in the experimental group of 3 intra-articular injection of 50mg doxycycline spaced every two weeks. Both groups will begin a standardized physical therapy program within a pain-free range of motion 4 weeks after the initiation of treatment. We will prospectively follow patients for one year, with follow-up at 6 weeks, 12 weeks, 6 months, and 12 months after the initiation of treatment. Outcomes will be measured using the American Shoulder and Elbow Score (ASES) and objective measurements of shoulder range of motion, which will be collected by the treating physician. Both the patients and physicians participating in the study will be blinded.

Timeline

Start
2018-03-05
Primary completion
2022-02-08
Completion
2022-02-08

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Doxycycline Small molecule 50 mg Intrathecal
Comparator Methylprednisolone Other / unclassified 40 mg Intrathecal

Indications